510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953444Substantially Equivalent

Mci Optonix Economy Cassette

Mci Optonix, Cedar Knolls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953444 is the FDA 510(k) clearance record for MCI OPTONIX ECONOMY CASSETTE, a class II device, cleared for Mci Optonix, Inc. on under FDA product code IXA (Cassette, Radiographic Film). FDA records list 4 510(k) clearances for Mci Optonix, Inc., from to . As of , FDA records show no recalls naming K953444.

Clearance record

Decision date
Received
(16 days to decision)
Product code
IXA Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Applicant
Mci Optonix, Inc. P.O. Box I, Cedar Knolls NJ
510(k) summary
Statement
Third party review
No

Clearances, product code IXA

Trailing 12 months

FDA records hold no clearances under product code IXA in the trailing twelve months.

FDA records show no clearances under product code IXA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260